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Safety and Risk of Medication Overuse Headache in Lasmiditan and Second-Generation Gepants: A Rapid Review. 拉米替坦和第二代患者用药过度头痛的安全性和风险:快速回顾。
IF 1.6 Q3 Medicine Pub Date : 2021-11-23 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S304373
Flavia Lo Castro, Simona Guerzoni, Lanfranco Pellesi

The treatment of migraine is often complicated by insufficient headache relief, a miscellany of side effects and the risk of developing Medication Overuse Headache (MOH). Novel acute therapies have been recently developed and are now in the early post-marketing phase. Lasmiditan is a highly selective serotonin receptor agonist that binds to the 5-HT1F receptor, while ubrogepant and rimegepant antagonize the calcitonin gene-related peptide receptor. All three medications are now prescribed in a real-world setting, and an adequate level of knowledge is the starting point for rational use. In this rapid systematic review, we have established what is known about lasmiditan, ubrogepant and rimegepant, highlighting the most relevant safety aspects available from published studies and speculating about their risk of MOH.

偏头痛的治疗往往因头痛缓解不足、各种副作用和发生药物过度使用头痛(MOH)的风险而复杂化。新的急性治疗最近被开发出来,目前处于上市后的早期阶段。拉斯米坦是一种高选择性血清素受体激动剂,可与5-HT1F受体结合,而ubrogetant和rimegetant可拮抗降钙素基因相关肽受体。这三种药物现在都在现实环境中开处方,适当的知识水平是合理使用的起点。在这一快速系统综述中,我们确定了关于lasmiditan、ubrogeants和rimegeants的已知信息,强调了从已发表的研究中可获得的最相关的安全性方面,并推测了它们的卫生部风险。
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引用次数: 2
Overprescribing of Topical Ocular Corticosteroids and Antibiotics in Out-of-Hours Primary Care in Belgium. 在比利时的非工作时间的初级保健过度处方局部眼皮质类固醇和抗生素。
IF 1.6 Q3 Medicine Pub Date : 2021-11-23 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S339141
Hans De Loof, Ellen De Win, Nathalie Moens, Veronique Verhoeven, Paul Van Royen, Elke O Kreps, Hilde Philips

Prescribing patterns by primary care physicians concerning ophthalmic problems were studied using the iCAREdata, a database containing information from the out-of-hours care setting in the Flanders region of Belgium. A very high percentage of prescribed ophthalmic medication was topical antibiotics (89.4%) with tobramycin as the most prevalent substance and in clear conflict with the prevailing guidelines. In addition, a very substantial fraction of prescribed medication contained corticosteroids (30.4%). This is a potentially unsafe option within the technical infrastructure of this setting, which limits the diagnostic possibilities concerning viral infections or preexisting glaucoma risk. We conclude that more efforts are required to limit unnecessary and inappropriate prescribing behavior to further promote patient safety.

使用iCAREdata(一个包含比利时法兰德斯地区非工作时间护理设置信息的数据库)研究了初级保健医生关于眼科问题的处方模式。眼药处方中外用抗生素的比例非常高(89.4%),妥布霉素是最常见的物质,与现行指南明显冲突。此外,很大一部分处方药含有皮质类固醇(30.4%)。在该环境的技术基础设施中,这是一种潜在的不安全选择,这限制了关于病毒感染或先前存在的青光眼风险的诊断可能性。我们的结论是,需要更多的努力来限制不必要和不适当的处方行为,以进一步促进患者的安全。
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引用次数: 1
Medication Errors Among Hospitalized Adults in Medical Wards of Nekemte Specialized Hospital, West Ethiopia: A Prospective Observational Study. 埃塞俄比亚西部Nekemte专科医院病房住院成人用药错误:一项前瞻性观察研究
IF 1.6 Q3 Medicine Pub Date : 2021-11-08 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S328824
Mohammed Gebre, Nigatu Addisu, Ayantu Getahun, Jenber Workye, Busha Gamachu, Ginenus Fekadu, Tesfa Tekle, Bizuneh Wakuma, Getahun Fetensa, Balisa Mosisa, Getu Bayisa

Purpose: A high prevalence of medication errors in older adults are due to a combination of different factors such as polypharmacy, polymorbidity, enrolment in several disease-management programs, and fragmentation of care that causes medication errors in all age groups. This study aims to assess the incidence and determinants of medication errors among hospitalized adults in medical wards of Nekemte Specialized Hospital (NSH), West Ethiopia.

Patients and methods: A prospective observational study design was conducted at Nekemte Specialized Hospital among hospitalized adults from October 30, 2018 to January 30, 2019. Data were collected by using checklist-guided observation and review of medication order sheets, medication administration records, and patient charts. To identify the independent predictors of medication errors, logistic regression analysis was used. Statistical significance was considered at a p-value <0.05.

Results: A total of 351 patients were included in the present study. The mean age of the patients was 40.67+15.78 years. A total of 813 medication errors were recorded. The most common stage for medication errors was physician ordering 263 (32.4%). In the multivariable analysis, age ≥65 years (AOR: 2.54, 95%CI: 1.12-5.75, p=0.025), hospital stay ≥7 days (AOR: 2.16, 95%CI: 1.17-3.98, p=0.014), number of medication taken (AOR: 1.75, 95%CI: 1.13-2.73, p=0.013) and presence of comorbidity (AOR: 1.57, 95%CI: 1.01-2.46, p=0.049) had shown statistical significance in predicting medication errors.

Conclusion: Medication errors are common at Nekemte Specialized Hospital with an incidence of 48.3 per 100 orders, 231.6 per 100 admissions, and 433.4 per 1000 patient days. In particular, adults with older age, increased hospital stay, a greater number of medications, and presence of comorbidities were at greater risk for medication errors.

目的:老年人用药错误的高发是由多种因素共同造成的,如多种用药、多发病、参加多个疾病管理项目以及导致所有年龄组用药错误的护理分散。本研究旨在评估在Nekemte专科医院(NSH),西埃塞俄比亚的医疗病房住院成人用药错误的发生率和决定因素。患者和方法:2018年10月30日至2019年1月30日,在Nekemte专科医院住院的成年人中进行前瞻性观察性研究设计。数据收集采用核对表引导观察和审查药物单,给药记录和患者图表。为确定用药差错的独立预测因子,采用logistic回归分析。结果:本研究共纳入351例患者。患者平均年龄40.67+15.78岁。共记录了813例用药错误。用药错误最常见的阶段是医生嘱咐263次(32.4%)。多变量分析中,年龄≥65岁(AOR: 2.54, 95%CI: 1.12-5.75, p=0.025)、住院天数≥7天(AOR: 2.16, 95%CI: 1.17-3.98, p=0.014)、用药次数(AOR: 1.75, 95%CI: 1.13-2.73, p=0.013)、是否存在共病(AOR: 1.57, 95%CI: 1.01-2.46, p=0.049)对预测用药错误有统计学意义。结论:Nekemte专科医院用药差错发生率为48.3 / 100次医嘱、231.6 / 100次住院、433.4 / 1000患者日。特别是,年龄较大、住院时间较长、用药数量较多、存在合并症的成年人发生用药错误的风险较大。
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引用次数: 7
A Narrative Review of Statin-Induced Rhabdomyolysis: Molecular Mechanism, Risk Factors, and Management. 他汀类药物诱导的横纹肌溶解:分子机制、危险因素和管理。
IF 1.6 Q3 Medicine Pub Date : 2021-11-08 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S333738
Nisa Safitri, Maya Fadila Alaina, Dian Ayu Eka Pitaloka, Rizky Abdulah

Although statins are effective for treating hypercholesterolemia, they can have various side effects, including rhabdomyolysis, a potentially fatal condition. This review evaluated the incidence and underlying molecular mechanism of statin-induced rhabdomyolysis and analyzed its risk factors, prevention, and management. We focused on the clinical and randomized clinical trials of statin monotherapies and combinations with other drugs. The primary mechanism of statin therapy-induced rhabdomyolysis is believed to be a decrease in ubiquinone (coenzyme Q) produced by the HMG-CoA pathway. Additionally, different types of lipophilic and hydrophilic statins play a role in causing rhabdomyolysis. Although statin-induced rhabdomyolysis has a low incidence, there is no guarantee that patients will be free of this side effect. Rhabdomyolysis can be prevented by reducing the risk factors, such as using CYP3A4 inhibitors, using high-dose statins, and strenuous physical activities.

尽管他汀类药物对治疗高胆固醇血症是有效的,但它们可能有各种副作用,包括横纹肌溶解,这是一种潜在的致命疾病。本文综述了他汀类药物诱导横纹肌溶解的发生率和潜在的分子机制,并分析了其危险因素、预防和管理。我们关注他汀类药物单药治疗和与其他药物联合的临床和随机临床试验。他汀类药物治疗诱导横纹肌溶解的主要机制被认为是由HMG-CoA途径产生的泛醌(辅酶Q)的减少。此外,不同类型的亲脂和亲水他汀类药物在引起横纹肌溶解中起作用。虽然他汀类药物引起的横纹肌溶解发病率低,但不能保证患者不会有这种副作用。横纹肌溶解可以通过减少危险因素来预防,例如使用CYP3A4抑制剂,使用高剂量他汀类药物和剧烈的体育活动。
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引用次数: 12
Reviewing Potentially Inappropriate Medication in Hospitalized Patients Over 65 Using Explicit Criteria: A Systematic Literature Review. 使用明确标准评价65岁以上住院患者潜在不适当用药:系统文献综述。
IF 1.6 Q3 Medicine Pub Date : 2021-11-03 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S303101
Hesah Alshammari, Eman Al-Saeed, Zamzam Ahmed, Zoe Aslanpour

Potentially inappropriate medication (PIM) is a primary health concern affecting the quality of life of patients over 65. PIM is associated with adverse drug reactions including falls, increased healthcare costs, health services utilization and hospital admissions. Various strategies, clinical guidelines and tools (explicit and implicit) have been developed to tackle this health concern. Despite these efforts, evidence still indicates a high prevalence of PIM in the older adult population. This systematic review explored the practice of using explicit tools to review PIM in hospitalized patients and examined the outcomes of PIM reduction. A literature search was conducted in several databases from their inception to 2019. Original studies that had an interventional element using explicit criteria detecting PIM in hospitalized patients over 65 were included. Descriptive narrative synthesis was used to analyze the included studies. The literature search yielded 6116 articles; 25 quantitative studies were included in this systematic literature review. Twenty were prospective studies and five were retrospective. Approximately, 15,500 patients were included in the review. Various healthcare professionals were involved in reviewing PIM including physicians and hospital pharmacists. Several tools were used to review PIM for hospitalized patients over 65, most frequently Beer's criteria and the STOPP/START tool. The reduction of PIM ranged from 3.5% up to 87%. The most common PIM were benzodiazepines and antipsychotics. This systematic review showed promising outcomes in terms of improving patient outcomes. However, the reduction of PIM varied in the studies, raising the question of the variance between hospitals in the explicit tools used for review. Additional studies need to be conducted to further investigate the outcomes of reviewing PIM at different levels, as well as assessing the cost-effectiveness of using explicit tools in reducing PIM.

潜在不适当用药(PIM)是影响65岁以上患者生活质量的主要健康问题。PIM与药物不良反应有关,包括跌倒、医疗费用增加、卫生服务利用和住院。已经制定了各种战略、临床指南和工具(明确的和隐含的)来解决这一健康问题。尽管做出了这些努力,但证据仍然表明,PIM在老年人中的患病率很高。本系统综述探讨了使用明确的工具来评估住院患者PIM的实践,并检查了PIM降低的结果。从建立到2019年,在几个数据库中进行了文献检索。纳入了使用明确标准检测65岁以上住院患者PIM的介入因素的原始研究。采用描述性叙事综合法对纳入的研究进行分析。文献检索得到6116篇;本系统文献综述纳入了25项定量研究。20项为前瞻性研究,5项为回顾性研究。大约15,500名患者被纳入该综述。各种医疗保健专业人员参与了PIM的审查,包括医生和医院药剂师。有几种工具用于评估65岁以上住院患者的PIM,最常见的是Beer标准和STOPP/START工具。PIM的降低幅度从3.5%到87%不等。最常见的PIM是苯二氮卓类药物和抗精神病药物。该系统综述显示了改善患者预后的良好结果。然而,在研究中,PIM的减少有所不同,这就提出了用于审查的明确工具在医院之间差异的问题。需要进行更多的研究,以进一步调查在不同层次审查PIM的结果,并评估使用明确工具减少PIM的成本效益。
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引用次数: 12
Self-Medication Practices with Antibiotics and Associated Factors among the Public of Malaysia: A Cross-Sectional Study. 自我用药实践与抗生素和相关因素在马来西亚的公众:横断面研究。
IF 1.6 Q3 Medicine Pub Date : 2021-10-28 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S331427
Adeel Aslam, Che Suraya Zin, Norny Syafinaz Ab Rahman, Márió Gajdács, Syed Imran Ahmed, Shazia Jamshed

Background: Self-medication with antibiotics (SMA) is an important public health issue, which can result in the facilitated development of antibiotic resistance, and may increase the risk of inappropriate utilization of antibiotics. So, the objective of the present study was to estimate the prevalence rate of SMA and to also explore SMA practices among the lay population of Kuala Lumpur (Malaysia).

Methods: The current study was cross-sectional population-based and used a convenient sampling technique. Moreover, Lorenz's formula was used to calculate the sample size and the required sample size was 480. Data were collected through face-to-face interviews with a pre-validated questionnaire and the study was conducted in Kuala Lumpur (Malaysia). Descriptive statistics, cross-tabulation, and logistic regression were executed by using SPSS version 24.

Results: Out of 480 participants, 45.8% were polled male and the prevalence of SMA in this study was found to be 15.1%. The majority of participants 23.1% indicated that they practiced antibiotics at least once in the last six months. The commonly self-medicated antibiotics were amoxicillin-clavulanate 20.6%, ampicillin/cloxacillin 14.2%, and levofloxacin 8.3%. Moreover, 64.8% of participants indicated that they bought their antibiotics from pharmacies. Whereas, most of the participants practice antibiotics to save money 19.2% and time 23.1%. Findings from multivariate logistic regressions showed that predictors of SMA were male gender, (95% CI: 0.300-0.877) occupation (95% CI: 0.122-10.797), health insurance (95% CI: 0.025-0.472), and education (95% CI: 0.084-0.800).

Conclusion: The results of this study indicate that SMA persists among the community and education level has a significant impact on this behavior. Thus, concerning health management authorities should step in with developing legislation to stop this practice, and by implementing such interventions and policies to educate and to raise awareness about the risk of SMA for the future.

背景:抗生素自我药疗(SMA)是一个重要的公共卫生问题,它可能导致抗生素耐药性的发展,并可能增加抗生素不当使用的风险。因此,本研究的目的是估计SMA的患病率,并探讨SMA在吉隆坡(马来西亚)非专业人群中的实践。方法:本研究以横断面人群为基础,采用方便的抽样技术。使用Lorenz公式计算样本量,所需样本量为480。数据是通过面对面访谈和预先验证的问卷收集的,研究在吉隆坡(马来西亚)进行。采用SPSS version 24进行描述性统计、交叉表和逻辑回归分析。结果:在480名参与者中,45.8%为男性,本研究中SMA的患病率为15.1%。大多数参与者(23.1%)表示,他们在过去六个月内至少使用过一次抗生素。常用的自用药抗生素为阿莫西林-克拉维酸20.6%,氨苄西林/氯西林14.2%,左氧氟沙星8.3%。此外,64.8%的参与者表示他们从药店购买抗生素。然而,大多数参与者使用抗生素是为了节省19.2%的金钱和23.1%的时间。多因素logistic回归结果显示,SMA的预测因子为男性性别(95% CI: 0.300-0.877)、职业(95% CI: 0.122-10.797)、医疗保险(95% CI: 0.025-0.472)和教育(95% CI: 0.084-0.800)。结论:本研究结果表明,SMA在社区中持续存在,教育水平对这种行为有显著影响。因此,有关卫生管理当局应介入,制定立法,制止这种做法,并通过实施此类干预措施和政策,教育和提高对未来SMA风险的认识。
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引用次数: 11
Rational Drug Use Evaluation Based on World Health Organization Core Drug Use Indicators in Ethiopia: A Systematic Review. 基于世卫组织核心用药指标的埃塞俄比亚合理用药评价:系统回顾。
IF 1.6 Q3 Medicine Pub Date : 2021-07-27 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S311926
Birye Dessalegn Mekonnen, Mekuanent Zemene Ayalew, Asnakew Asres Tegegn

Background: Rational use of medicines plays a vital role in avoiding preventable adverse drug effects, maximizing therapeutic outcomes with promoting patient adherence, and minimizing the cost of drug therapy. Irrational use of drugs is often observed in countries with weak health care systems. No review has been done that systematically expresses rational drug use practice based on the three WHO core drug use indicators in Ethiopia. Thus, this study was aimed to review systematically the prescribing, health-facility, and patient-care indicators based on WHO core drug use indicators in Ethiopia.

Methods: A systematic article search was conducted in different electronic databases including PubMed/ MEDLINE, the Cochrane Library, EMBASE, Web of Science, POPLINE, the Global Health, and Google scholar. Quality assessment was conducted using Newcastle-Ottawa quality assessment scale. Studies were synthesized and grouped in to prescribing, patient care and health facility indicators.

Results: From a total of 6239 articles, 21 studies were found suitable for the review. The highest average number of drugs per encounter was 2.5 while the lowest was 0.98. The percentage of generic drug use was ranged from 70.5% to 100%. The highest percentage of encounters with an antibiotic was 85%. The lowest percentage of drugs prescribed from essential drugs list was 81.4%. The highest percentage of drugs actually dispensed and adequately labeled was 96.16% and 96.25%, respectively.

Conclusion: This study showed that the practice of rational drug use varied across region of the country. The average number of drugs per prescription, percentage of drugs encounter with antibiotics, drugs prescribed by their generic name, average consultation time, average dispensing time, percentage of drugs adequately labeled, and availability of essential drugs showed deviation from the standard recommended by WHO. Thus, provision of regular training for prescribers and pharmacists, and ensuring the availability of essential drugs should be encouraged.

背景:合理用药在避免可预防的药物不良反应、提高患者依从性、最大化治疗效果和最小化药物治疗成本方面起着至关重要的作用。在卫生保健系统薄弱的国家经常观察到不合理的药物使用。没有根据世卫组织在埃塞俄比亚的三个核心药物使用指标系统地表达合理药物使用做法的审查。因此,本研究旨在根据世卫组织在埃塞俄比亚的核心药物使用指标系统地审查处方、卫生设施和患者护理指标。方法:系统检索PubMed/ MEDLINE、Cochrane Library、EMBASE、Web of Science、POPLINE、the Global Health、Google scholar等电子数据库中的文章。采用纽卡斯尔-渥太华质量评价量表进行质量评价。对研究进行了综合,并按处方、病人护理和卫生设施指标进行了分组。结果:从总共6239篇文章中,发现21项研究适合本综述。每次接触药物的平均数量最高为2.5,最低为0.98。仿制药使用率为70.5% ~ 100%。接触抗生素的最高比例为85%。基本药物目录中药品使用比例最低,为81.4%。实际配药和充分标注的药品比例最高,分别为96.16%和96.25%。结论:本研究表明,全国各地合理用药实践存在差异。每张处方的平均药物数量、遇到抗生素的药物百分比、按其通用名开具的药物、平均咨询时间、平均调剂时间、充分贴有标签的药物百分比以及基本药物的可得性均与世卫组织建议的标准存在偏差。因此,应鼓励对开处方者和药剂师提供定期培训,并确保基本药物的供应。
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引用次数: 12
Quetiapine, Misuse and Dependency: A Case-Series of Questions to a Norwegian Network of Drug Information Centers. 喹硫平,滥用和依赖:挪威药物信息中心网络的案例系列问题。
IF 1.6 Q3 Medicine Pub Date : 2021-07-21 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S296515
Jan Anker Jahnsen, Sofia Frost Widnes, Jan Schjøtt

Purpose: The second-generation antipsychotic quetiapine has been associated with misuse and dependency. We aimed to review questions to the Norwegian network of drug information centers concerning this potential drug safety problem.

Methods: We conducted a Boolean search in the database of the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS) combining the indexed categories "quetiapine" and "adverse drug reaction" with the text words "misuse" or "dependency". Question-answer pairs (Q/As) in the full-text, searchable RELIS database were defined as cases. Cases were analyzed for drug safety issues linked to use of quetiapine, including off-label use, polypharmacy and other patient risk factors.

Results: The search resulted in 54 cases. Forty-six cases (85%) were patient-related, and a majority came from physicians working in hospitals. Twenty-nine cases (54%) concerned patients with a history of addiction, 14 cases (26%) had polypharmacy, and off-label use of quetiapine for insomnia was identified in 14 of the cases (26%). Only three of the cases included a specific question about patient dependency of quetiapine, and these cases were all associated with insomnia.

Conclusion: We conclude that our case series from the Norwegian network of drug information centres reflects that quetiapine frequently involves clinical narratives of a history of addiction, polypharmacy or insomnia (off-label use). However, the case series did not reveal new information about the drug's addictive potential.

目的:第二代抗精神病药物喹硫平与滥用和依赖有关。我们的目的是向挪威药物信息中心网络审查有关这一潜在药物安全问题的问题。方法:在挪威区域药物信息和药物警戒中心(RELIS)数据库中进行布尔搜索,将索引类别“喹硫平”和“药物不良反应”与文本词“滥用”或“依赖”结合起来。全文可检索的RELIS数据库中的问答对(Q/As)定义为案例。病例分析与喹硫平使用相关的药物安全问题,包括超说明书使用、多种用药和其他患者风险因素。结果:共检索54例。46例(85%)与患者有关,大多数来自在医院工作的医生。29例(54%)患者有喹硫平成瘾史,14例(26%)患者有多种用药史,其中14例(26%)患者有喹硫平超说明书用药。只有三个病例包含了关于患者对喹硫平依赖的具体问题,这些病例都与失眠有关。结论:我们的结论是,来自挪威药物信息中心网络的病例系列反映了喹硫平经常涉及成瘾史,多种药物或失眠(标签外使用)的临床叙述。然而,该病例系列并没有揭示有关该药物成瘾性的新信息。
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引用次数: 2
Patient Safety Culture and Associated Factors Among Health-Care Providers in the University of Gondar Comprehensive Specialized Hospital, Northwest Ethiopia. 埃塞俄比亚西北部贡达尔大学综合专科医院医护人员的患者安全文化及相关因素
IF 1.6 Q3 Medicine Pub Date : 2021-07-02 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S291012
Aynalem Ayisa, Yalemwork Getahun, Nurhussien Yesuf

Introduction: Patient safety is an issue of global concern; however, health-care organizations have lately observed to pay more attention to the importance of establishing a culture of safety. The study aimed to assess the level of patient safety culture and associated factors among health-care providers at the University of Gondar comprehensive specialized hospital, Northwest Ethiopia, 2020.

Methods: A cross-sectional study design supported by the qualitative approach was conducted from March 15 to May 15/2020. A stratified simple sampling technique was used to select 575 study participants. The standardized tool, which measures 12 safety culture dimensions, was used for data collection. Bivariate and multivariable linear regression analyses performed using SPSS version 23. The significance level was obtained at 95% CI and p-value <0.05. For the qualitative part, a semi-structured interview guide with probing was used. Data were analyzed thematically using open code software version 4.02.

Results: The overall level of positive patient safety culture was 45.3% (95% CI: 44.7, 45.9) with a response rate of 92.2%. Factor analysis indicated that female, masters, participation in patient safety program, adverse event report, hospital management encourage reporting event and resource were positively associated with the patient safety culture. Whereas divorced/widowed, midwives, anesthetist, medicine, pediatrics, emergency, outpatient, pharmacy, direct contact with patients, and hospital management blame when medical errors happened were negatively associated. The in-depth interview revealed that teamwork, health-care professionals' attitude toward patient safety and patient involvement as important factors that influence patient safety culture.

Conclusions and recommendations: The overall level of positive patient safety culture was low. All variables except age, training, working hour, and working experience were factors significantly associated with the patient safety culture. Health-care policy-makers and managers should consider patient safety culture a top priority, and also create a blame-free environment that promotes event reporting.

患者安全是一个全球关注的问题;然而,保健组织最近注意到,它们更加重视建立安全文化的重要性。该研究旨在评估2020年埃塞俄比亚西北部贡达尔大学综合专科医院医护人员的患者安全文化水平及其相关因素。方法:采用横断面研究设计,采用定性方法,研究时间为2020年3月15日至2020年5月15日。采用分层简单抽样方法,共选取575名研究对象。该标准化工具测量了12个安全文化维度,用于数据收集。使用SPSS版本23进行双变量和多变量线性回归分析。结果:患者安全培养总体阳性水平为45.3% (95% CI: 44.7, 45.9),有效率为92.2%。因子分析显示,女性、硕士、患者安全计划参与、不良事件报告、医院管理鼓励报告事件和资源与患者安全文化呈正相关。而离婚/丧偶、助产士、麻醉师、内科、儿科、急诊、门诊、药房、与患者直接接触者、医院管理人员在发生医疗差错时的责任负相关。深入访谈发现,团队合作、医护人员对患者安全的态度和患者参与是影响患者安全文化的重要因素。结论和建议:患者安全培养阳性总体水平较低。除年龄、培训、工作时间和工作经验外,所有变量都是与患者安全文化显著相关的因素。卫生保健政策制定者和管理人员应将患者安全文化视为重中之重,并创造一个没有指责的环境,促进事件报告。
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引用次数: 11
Adulterated Traditional-Herbal Medicinal Products and Its Safety Signals in Malaysia. 马来西亚掺假传统草药产品及其安全信号。
IF 1.6 Q3 Medicine Pub Date : 2021-06-08 eCollection Date: 2021-01-01 DOI: 10.2147/DHPS.S305953
Suriana Hanim Ariffin, Izyan A Wahab, Yahaya Hassan, Mohd Shahezwan Abd Wahab

Background: Usage of traditional-herbal medicines (THM) for various illnesses has been increased around the world, so does the adulteration of these products with hazardous compounds. There are limited Malaysian data that have been published on the characteristics trend and adverse events associated with adulterated THM products.

Aim: This study described characteristics of adulterated THM products in Malaysia and aimed to quantify THM products' safety signals of adverse reactions (ARs).

Methods: THM products that were seized by Pharmacy Enforcement Division between 2008 and 2014 were extracted and analysed for 59,440 THM products. Of these, only 6452 THM products with complete information were included in the final analyses. Safety signalling tools were used to measure AR signals from AR reports obtained from the National Pharmaceutical Regulatory Agency Adverse Drug Reaction Database.

Results: More than half of adulterated THM products originated from countries outside of Malaysia, with the majority were from Indonesia. The most common claimed indication of adulterated THM products was for pain and fever relief, while steroids were the most common adulterant. AR signals were generated for cough and cold products for respiratory and thoracic disorders, weight-loss products for cardiac disorders, and women's health products for reproductive and breast disorders.

Conclusion: Health authorities from various fields can work collaboratively by implementing strategic actions that include the use of safety signalling tools to curb the increasing number of adulterated THM products in the Malaysian market.

背景:世界各地使用传统草药(THM)治疗各种疾病的情况越来越多,这些产品中掺杂有害化合物的情况也越来越多。关于掺假传统草药产品的特征趋势和相关不良事件,马来西亚公布的数据有限。目的:本研究描述了马来西亚掺假传统草药产品的特征,旨在量化传统草药产品的不良反应(ARs)安全信号:提取并分析了药剂执法部门在 2008 年至 2014 年期间查获的 59,440 种 THM 产品。其中,只有 6452 种信息完整的 THM 产品被纳入最终分析。从国家药品监管局药品不良反应数据库中获取的药品不良反应报告中,使用安全信号工具来测量药品不良反应信号:一半以上的掺假 THM 产品来自马来西亚以外的国家,其中大部分来自印度尼西亚。掺假的 THM 产品最常见的声称适应症是止痛和退烧,而类固醇是最常见的掺假物质。针对呼吸道和胸腔疾病的咳嗽和感冒产品、针对心脏疾病的减肥产品以及针对生殖和乳腺疾病的妇女保健产品都产生了急性呼吸系统反应信号:来自不同领域的卫生当局可以通过实施包括使用安全信号工具在内的战略行动,共同遏制马来西亚市场上日益增多的三卤甲烷掺假产品。
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Drug, Healthcare and Patient Safety
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